Medical device adapter

ABSTRACT

An adapter constructed to have a proximal portion that interfaces with the internal lumen of a medical device and a distal portion that modifies, augments or extends the configuration or intended use of the medical device. The proximal portion of the adapter interfaces with the internal lumen of the medical device in a manner to secure the adapter to the medical device during use. The distal portion of the adapter is generally outside the lumen of the catheter or device.

CROSS REFERENCE TO RELATED APPLICATION

This application is a continuation of prior U.S. application Ser. No.15/196,952 filed Jun. 29, 2016, which claims the benefit of U.S.Provisional Patent Application Nos. 62/188,363 filed Jul. 2, 2015;62/249,482 filed Nov. 2, 2015; 62/279,858 filed Jan. 18, 2016; and62/325,700 filed Apr. 21, 2016; the entireties of which applications arehereby incorporated by reference into this application.

BACKGROUND OF THE INVENTION Field of the Invention

The present invention relates generally to a design of an adapter for amedical device for use in the body and more specifically to an adapterintended to convert or augment the medical device, for example acatheter, such that the purpose or configuration of the medical deviceis modified or expanded.

Description of the Related Art

Catheter type devices are typically long tubular structures with aninner lumen suitable for a guidewire used to navigate the vasculature,inject contrast or therapeutic materials, aspirate thrombus, or providea means to deliver other devices or therapies to a target site withinthe vasculature or other body lumen. Catheter type devices are typicallyinserted through a small opening in the skin or another opening undervisual guidance tracked to the target location within the body.

U.S. Patent Application Publication No. 2007/0244440 discloses a medicaldevice including a catheter with an expandable tip for use with at leasttwo different sizes of wire guides. The catheter includes a wire guidelumen sized to receive a first wire guide of a first diameter. Thecatheter may also include a tip lumen that extends in a distal directionfrom a first opening in communication with the wire guide lumen to asecond opening. The first opening is sized to receive the first wireguide, and the second opening is sized to receive a second wire guide ofa smaller diameter than the first wire guide. The catheter also includesone or more longitudinal expansion features capable of radiallyexpanding the tip lumen to receive a wire guide of a diameter up to thefirst diameter through the second opening.

U.S. Pat. No. 8,100,884 discloses an adapter assembly for connecting acatheter assembly to a tunneler having a generally tubular body having afirst end, a second end and a longitudinal axis extending there throughbetween the first end and the second end. The first end of the adapteris constructed to engage the proximal end of a trocar. The second end ofthe adapter is constructed to releasably engage at least one catheterlumen. A slider is disposed about the adapter and is longitudinallyslidable along the adapter. When the slider is slid towards the secondend of the adapter, the slider engages a plurality of legs on theadapter and biases the plurality of legs toward each other and thelongitudinal axis of the adapter.

U.S. Pat. No. 8,523,840 discloses coupler assemblies to be used with acatheter to connect a proximal end of the catheter to extracorporealmedical equipment. An exemplary coupler assembly includes a sphericallinkage coupler for a catheter. The coupler comprises a first cylinderportion for connecting to a structure, and a second cylinder portion forconnecting to a distal end of a body of the catheter. The coupler alsocomprises a spherical linkage including at least two link arms. Each ofthe two link arms are connected on one end to the first cylinder portionand on the other end to the second cylinder portion. The two link armsconnect a portion of the structure to the distal end of the catheter andenable the structure to move relative to the distal end of the catheterin response to an external force exerted on the structure.

It is desirable to provide an improved adapter designed with featuresthat expand, augment, or modify the configuration or intended use of amedical device. The adapter including geometry, mechanical and/orthermal properties to expeditiously attach to the medical device, suchas a catheter. In one embodiment, the adapter provides conversion of themedical device from a single guidewire device to a two guidewire device.

SUMMARY OF THE INVENTION

In accordance with the present invention, an adapter is constructed tohave a proximal portion that interfaces with the internal lumen of amedical device and a distal portion that modifies, augments or extendsthe configuration or intended use of the medical device. The medicaldevice can be a catheter. The proximal portion of the adapter interfaceswith the internal lumen of the medical device in a manner to secure theadapter to the medical device during use. The distal portion of theadapter is generally outside the lumen of the catheter or device and isdesigned with features that expand, augment, or modify the configurationor intended use of the medical device.

The proximal portion of the adapter is designed to provide aninterference fit with an internal lumen of the medical device such thatduring subsequent use the adapter remains secure. The proximal portionis additionally designed to be easily inserted into the internal lumenof medical device. In one embodiment, the proximal portion of theadapter includes a coil structure having geometry and mechanical/thermalproperties such that the structure is slightly smaller than the internallumen to fit within the internal lumen in the operating room environmenttemperature and then expands to a larger size to secure the adapter tothe internal lumen of the medical device when it is in-vivo closer tobody temperature. For example, the coil structure can be formed ofnitinol at a predetermined austentic finish (AF) temperature less thanbody temperature but greater than the temperature typically expected inan operating room or catheter lab. Alternatively, the coil structure canbe physically restrained to have a size smaller than the internal lumenin the operating room environment and then expands to interface with theinternal lumen of the medical device once the adapter is seated with themedical device and the physical restraint is removed. Alternatively, thecoil structure can be configured to compress as it is inserted into theinternal lumen of the medical device and provide securement.

The proximal portion can include an internal lumen to preserve a pathfor a guidewire, or for contrast injection for example. The proximalportion can include a braided structure or slotted tube stent-likegeometry which can be compressed to a smaller size and then expanded tosecure the adapter to the internal lumen of the catheter or otherdevice.

The distal portion of the adapter can be used to modify theconfiguration of the medical device, for example, to convert a medicaldevice from a single guidewire device to a two (2) guidewire device.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing description, as well as further objects, features, andadvantages of the present invention will be understood more completelyfrom the following detailed description of presently preferred, butnonetheless illustrative embodiments in accordance with the presentinvention, with reference being had to the accompanying drawings, inwhich:

FIG. 1A is a schematic, longitudinal, cross-sectional view of anembodiment of an adapter in accordance with the teachings of the presentinvention and a partial schematic, longitudinal, cross-sectional view ofa distal end of a medical device.

FIG. 1B is an enlarged detail view of FIG. 1A, showing a proximal end ofthe adapter.

FIG. 1C is an enlarged detailed view of FIG. 1A, showing part of adistal portion of the adapter.

FIG. 2 is a schematic, longitudinal, cross-sectional view of the adapterwhere the coil of the adapter has been elongated in order to reduce thesize of the coil prior to insertion into the target medical device.Break line symbols are utilized to reduce the size of the drawing forclarity.

FIG. 3 is a schematic, longitudinal, cross-sectional view of the adapterwhere the coil of the adapter has been rotated or twisted in order toreduce the size of the coil prior to insertion into the target medicaldevice. Break line symbols are utilized to reduce the size of thedrawing for clarity.

FIG. 4 is a schematic, longitudinal, cross-sectional view of analternate embodiment of an adapter, and a partial schematic,longitudinal, cross-sectional view of a distal end of a medical device.Break line symbols are utilized to reduce the size of the drawing forclarity.

FIG. 5 is a schematic, longitudinal, cross-sectional view of analternate embodiment of an adapter, and a partial schematic,longitudinal, cross-sectional view of a distal end of a medical device.Break line symbols are utilized to reduce the size of the drawing forclarity.

FIG. 6 is a schematic, longitudinal, cross-sectional view of analternate embodiment of an adapter, and a partial schematic,longitudinal, cross-sectional view of a distal end of a medical device.Break line symbols are utilized to reduce the size of the drawing forclarity.

FIG. 7 is a schematic, longitudinal, cross-sectional view of analternate embodiment of an adapter, where a coil of the adapter has beenrotated or twisted in order to reduce the size of the coil prior toinsertion into the medical device. Break line symbols are utilized toreduce the size of the drawing for clarity.

FIG. 8A is a schematic, longitudinal, cross-sectional view of an adapteraccording an embodiment of the invention. Break line symbols areutilized to reduce the size of the drawing for clarity.

FIG. 8B is an enlarged detail view of FIG. 8A, showing a distal portionof the adapter.

FIG. 8C is an enlarged detail view of FIG. 8A, showing a proximal end ofa distal portion of the adapter.

FIG. 8D is an enlarged detail view of FIG. 8A, showing a distal end of adistal portion of the adapter.

FIG. 8E is an enlarged detail view of FIG. 8A, showing a proximalportion of the adapter.

FIG. 8F is an enlarged detail view of FIG. 8A, showing a proximal end ofa proximal portion of the adapter.

FIG. 9A is a schematic, longitudinal, cross-sectional view of an adapteraccording an embodiment of the invention. Break line symbols areutilized to reduce the size of the drawing or schematic for clarity.

FIG. 9B is an enlarged detail view of FIG. 9A, showing a distal portionof the adapter

FIG. 9C is an enlarged detail view of FIG. 9A, showing a proximalportion of the adapter.

FIG. 9D is an enlarged detail view of FIG. 9A, showing a distal end of adistal portion of the adapter.

FIG. 9E is an enlarged detail view of FIG. 9A, showing a proximal end ofa distal portion of the adapter.

FIG. 9F is an enlarged detail view of FIG. 9A, showing a proximal end ofa proximal portion of the adapter.

FIG. 9G is an enlarged detail view of FIG. 9A, showing middle elementsof a proximal portion of the adapter.

FIG. 9H is an enlarged detail view of FIG. 9A, showing a distal end of aproximal portion of the adapter.

FIG. 10A is a schematic, longitudinal, cross-sectional view of anadapter according to an embodiment of the invention having two coilelements in a proximal portion of the adapter. Break line symbols areutilized to reduce the size of the drawing for clarity.

FIG. 10B is an enlarged detail view of FIG. 10A, showing a distalportion of the adapter.

FIG. 10C is an enlarged detail view of FIG. 10A, showing a proximalportion of the adapter.

FIG. 10D is an enlarged detail view of FIG. 10A, showing a proximal endof a proximal portion of the adapter.

FIG. 10E is an enlarged detail view of FIG. 10A, showing a distal end ofa distal portion of the adapter.

FIG. 10F is an enlarged detail view of FIG. 10A, showing the proximalcoil element, coil located closer to the proximal end of the proximalportion of an adapter.

FIG. 10G is an enlarged detail view of FIG. 10A, showing the distal coilelement, coil located closer to the distal end of the proximal portionof an adapter.

FIG. 11A is a schematic, longitudinal, cross-sectional view of anadapter according an embodiment of the invention where a distal coilelement of the adapter has been rotated or twisted in order to reducethe size of the coil prior to insertion into the target catheter ordevice. Break line symbols are utilized to reduce the size of thedrawing for clarity.

FIG. 11B is an enlarged detail view of FIG. 11A, showing a proximalportion of the adapter.

FIG. 11C is an enlarged detail view of FIG. 11A, showing a distal end ofa proximal portion of the adapter.

FIG. 11D is an enlarged detail view of FIG. 11A, showing a distal end ofa proximal portion of the adapter and a proximal end of a distal portionof the adapter.

FIG. 12A is a schematic, longitudinal, cross-sectional view of anadapter according to an embodiment of the invention and a partialschematic, longitudinal, cross-sectional view of a distal end of amedical device, where a distal coil element of the adapter has beenrotated or twisted in order to reduce the size of the coil prior toinsertion into the target medical device and the proximal coil elementthat has been inserted into the medical device causing the proximal coilelement to elongate and reduce in diameter. Break line symbols areutilized to reduce the size of the drawing for clarity.

FIG. 12B is an enlarged detail view of FIG. 12A, showing a proximalportion of the adapter.

FIG. 12C is an enlarged detail view of FIG. 12A, showing a proximal endof a proximal portion of the adapter, including a proximal coil element.

FIG. 12D is an enlarged detail view of FIG. 12A, showing a distal end ofa proximal portion of the adapter and a proximal end of a distal portionof the adapter.

FIG. 13A is a schematic, longitudinal, cross-sectional view of anadapter according to an embodiment of the invention and a partialschematic, longitudinal, cross-sectional view of a distal end of amedical device, where a distal coil element of the adapter has beenrotated or twisted in order to reduce the size of the coil prior toinsertion into the medical device then subsequently released to expandto an inner lumen of the medical device, and a proximal coil elementthat has been inserted into the medical device causing the proximal coilelement to elongate and reduce in diameter. Break line symbols areutilized to reduce the size of the drawing for clarity.

FIG. 13B is an enlarged detail view of FIG. 13A, showing a proximalportion of the adapter.

FIG. 13C is an enlarged detail view of FIG. 13A, showing a proximal endof a proximal portion of the adapter, including a proximal coil element.

FIG. 13D is an enlarged detail view of FIG. 13A, showing a distal end ofa proximal portion of an adapter and a proximal end of a distal portionof the adapter.

FIG. 14A is a partial schematic, longitudinal, cross-sectional view ofan adapter according to an embodiment of the invention and a partialschematic, longitudinal, cross-sectional view of a distal end of amedical device, where a coil element of the adapter has been rotated ortwisted in order to reduce the size of the coil prior to insertion intoa medical device then subsequently released to expand to an inner lumenof the medical device, and a transverse cross-sectional view Z-Z of adistal portion of the adapter. Break line symbols are utilized to reducethe size of the schematic for clarity

FIG. 14B is an enlarged detail view of FIG. 14A, showing a proximal endof a distal portion of an adapter.

FIG. 14C is an enlarged detail view of FIG. 14A, showing a distal end ofa distal portion of the adapter and a transverse cross-sectional viewZ-Z of a distal portion of the adapter.

FIG. 15A is a partial schematic, longitudinal, cross-sectional view ofan adapter according an embodiment of the invention and a partialschematic, longitudinal, cross-sectional view of a distal end of amedical device, where a coil element of the adapter has been rotated ortwisted in order to reduce the size of the coil prior to insertion intothe medical device then subsequently released to expand to an innerlumen of the medical device and a first and second wire, and atransverse cross-sectional view Z-Z of a distal portion of the adapter.Break line symbols are utilized to reduce the size of the schematic forclarity, FIG. 15B is an enlarged detail view of FIG. 15A, showing aproximal end of a distal portion of the adapter.

FIG. 15C is an enlarged detail view of FIG. 15A, showing a distal end ofa distal portion of the adapter and a transverse cross-sectional viewZ-Z of a distal portion of the adapter.

FIG. 16A is a partial schematic, longitudinal, cross-sectional view ofan adapter according to an embodiment of the present invention and apartial schematic, longitudinal, cross-sectional view of a distal end ofa medical device, where a coil element of the adapter has been rotatedor twisted in order to reduce the size of the coil prior to insertioninto the medical device then subsequently released to expand to an innerlumen of the medical device, which also includes a first and secondwire, and a transverse cross-sectional view Z-Z of a distal portion ofthe adapter. Break line symbols are utilized to reduce the size of theschematic for clarity,

FIG. 16B is an enlarged detail view of FIG. 16A, showing a proximal endof a distal portion of the adapter.

FIG. 16C is an enlarged detail view of FIG. 16A, showing a distal end ofa distal portion of the adapter and a transverse cross-sectional viewZ-Z of a distal portion of the adapter.

FIG. 17A is a partial schematic, longitudinal, cross-sectional view ofan adapter according to an embodiment of the invention and a partialschematic, longitudinal, cross-sectional view of a distal end of amedical device, where a coil element of the adapter has been rotated ortwisted in order to reduce the size of the coil prior to insertion intothe target medical device then subsequently released to expand to aninner lumen of the medical device, and a transverse cross-sectionalviews Z-Z and Y-Y.

FIG. 17B is an enlarged detail view of FIG. 17A, showing a proximal endof a distal portion of the adapter.

FIG. 17C is an enlarged detail view of FIG. 17A, showing a distal end ofa distal portion of the adapter and a transverse cross-sectional viewsZ-Z and Y-Y.

FIG. 18A is a partial schematic, longitudinal, cross-sectional view of aproximal portion of an adapter according to an embodiment of theinvention. Break line symbols are utilized to reduce the size of thedrawing or schematic for clarity.

FIG. 18B is a partial schematic, longitudinal, cross-sectional view of aproximal portion of the adapter shown in FIG. 18A, where the adapter andproximal portion has been inserted into a medical device. Break linesymbols are utilized to reduce the size of the drawing or schematic forclarity.

FIG. 18C is a partial schematic, longitudinal, cross-sectional view of aproximal portion of the adapter shown in FIG. 18A, where the adapter andproximal portion has been inserted into a target medical device and atensile force has been transmitted to a central tube axially compressinga portion of a coil. Break line symbols are utilized to reduce the sizeof the drawing or schematic for clarity.

FIG. 18D is a partial schematic, longitudinal, cross-sectional view of aproximal portion of the adapter, where the adapter and proximal portionhas been inserted into a target medical device and a tensile force hasbeen transmitted to a central tube axially compressing a portion of acoil. Break line symbols are utilized to reduce the size of the drawingor schematic for clarity.

FIG. 18E is an enlarged detail view of FIG. 18C showing a compressedportion of the coil.

FIG. 18F is an enlarged detail view of FIG. 18D showing a compressedportion of the coil.

FIG. 19 is a partial schematic, longitudinal, cross-sectional view of aproximal portion of an adapter according to an embodiment of theinvention. Break line symbols are utilized to reduce the size of thedrawing or schematic for clarity.

FIG. 20A is a partial schematic, longitudinal, cross-sectional view of aproximal portion of an adapter according to an embodiment of theinvention. Break line symbols are utilized to reduce the size of thedrawing or schematic for clarity.

FIG. 20B is an enlarged detail view of FIG. 20A.

FIG. 21A is a partial schematic, longitudinal, cross-sectional view ofan adapter according to an embodiment of the invention, where theadapter has been inserted into a target medical device. Break linesymbols are utilized to reduce the size of the drawing or schematic forclarity.

FIG. 21B is an enlarged detail view of FIG. 21A.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Reference will now be made in greater detail to preferred embodiments ofthe invention, examples of which is illustrated in the accompanyingdrawings. Wherever possible, the same reference numerals will be usedthroughout the drawings and the description to refer to the same or likeparts.

FIG. 1A, FIG. 1B, and FIG. 1C illustrates one embodiment of adapter 10coupled to distal end 213 of medical device 200. A suitable medicaldevice 200 is a catheter. Adapter 10 includes distal portion 20 andproximal portion 30. Proximal portion 30 is predominately or entirelyinside lumen 211 of target medical device 200. Distal portion of adapter10 is predominately outside of target medical device 200. Adapter 10 isco-axial with medical device 200 as shown by longitudinal axis 11.Proximal portion 30 of adapter 10 includes coil 12. Preferably coil 12can be made of nitinol. Coil 12 can be comprised of wire with across-sectional size wound to form a general coil shape.

Coil 12 interfaces with lumen 211 of medical device 200 in a manner thatsecures adapter 10 to medical device 200. Adapter 10 can be secured tomedical device 200 by an interference fit of coil 12 with lumen 211.Coil 12 can have an austenitic finish temperature (Af) less than bodytemperature, such as an average of 37° C. of normal body temperature andgreater than a temperature typically expected in an operating room orcatheter lab, for example about 25 degrees to about 30 degrees C. Coil12 can be twisted and or elongated to reduce a size or diameter of coil12 such that coil 12 has a smaller size or diameter than a size ordiameter of lumen 211 to facilitate positioning adapter 10 insidemedical device 200. As adapter 10 warms to body temperature during usein-vivo, coil 12 can expand to provide additional securement to medicaldevice 200.

Alternatively, coil 12 can be designed to be physically restrained orconstrained to have a size or diameter smaller than internal lumen 211of medical device 200 in an operating room environment and coil 12 canexpand to interface with the internal lumen 211 of the target catheteror device 200 when the physical restraint is removed, once the adapter10 is seated within medical device 200. Coil 12 is shown with a constantround cross-section, alternatively the coil 12 can have a rectangularcross-section of a flat wire coil design. A flat wire design providesthe benefit of a lower profile coil 12 but still sufficient securementthrough an interference fit with lumen 211. The cross-section can bevariable along the length of coil 12. A variable cross-section coil 12design provides the advantage of biased securement either towards one ofends of adapter 10. Coil 12 can have variable flexibility and bendingabout longitudinal axis 11.

In one embodiment, coil 12, provides additional reinforcement of medicaldevice 200 to improve the kink resistance. Adapter 10 includes tube 16coupled to distal portion of adapter 10 and is co-axial with coil 12.Tube 16 has funnel portion 13 located at proximal end 30 of adapter 10.Funnel portion 13 can facilitate tracking of a guide wire from aproximal end (not shown), of medical device 200 to distal portion 20 ofadapter 10. Tube 16 preferably is a polymer tube and can includebraiding or other reinforcement. Coil 12 includes proximal end 15 thatis coupled, bonded or otherwise attached near proximal end 19 of tube16. Proximal end 15 of coil 12 can be retained to a size smaller than asize of lumen 211 to facilitate loading of adapter 10 into medicaldevice 200 in use. Distal end 14 of coil 12 can be retained to a sizesmaller than a size of lumen 211. For example, proximal end 15 or distalend 14 can be heat shaped or formed to a smaller size than the size oflumen 211.

Distal end 14 provides a location on coil 12 that can be grabbed or heldin order to twist and or elongate coil 12 to make it smaller in size tofacilitate positioning the adapter 10 inside medical device 200. Distalportion 20 of adapter 10 is preferably made from a thermoplasticelastomer. Example thermoplastic elastomers or soft polymers include,polyether urethane and polyether block amide, such as for example ˜40 DPEBAX manufactured by Arkema.

In this embodiment, distal portion 20 is designed to modify medicaldevice 200 that has a single guidewire access to have a two guidewireaccess. Distal portion 20 includes first lumen 21 for a first guidewireand second lumen 22. Second lumen 22 connects to lumen 211 of medicaldevice 200 by way of tube 16 of adapter 10. This allows the user extraflexibility, for example to exchange guidewires, or administer contrastor medications through the target catheter or device lumen 211. The pathof a first guidewire illustrated by first lumen centerline 23 and thepath of a second guidewire is illustrated by the second lumen centerline24. Accordingly, the path of lumen centerline 23 is outside of device200.

Distal portion 20 includes reduced size portion 17 at proximal end 26 ofdistal portion 20 which is designed through choice of materials, forexample thermoplastic elastomers or soft polymers and geometry tointerface with lumen 211 of medical device 200. A slight interferencefit between reduced size portion 17 and lumen 211 provides a stablestructure during introduction of the coupled adapter 10 and medicaldevice 200 into a body cavity or vessel. Adapter 10 can include atapered distal end 27 of distal portion 20 which facilitates trackingthe medical device 200 with attached adapter 10 inside a body lumen.

FIG. 2 illustrates adapter 10 in a configuration where coil 12 has beenreduced to a smaller size by elongating coil 12. FIG. 3 illustratesadapter 10 in a configuration where the coil 12 has been reduced to asmaller size by rotating or twisting coil 12. An alternate embodiment ofadapter 10 is where a combination of coil 12 twisting and elongatingreduces the size of coil 10 such that it can fit within medical device200. Distance Ds2 between distal end 14 of coil 12 and proximal end 26of distal portion 20 in FIG. 2 and FIG. 3 is smaller than distance Ds1between distal end 14 of coil 12 and proximal end 26 of distal portion20 as illustrated in FIG. 1C. In an alternate embodiment of adapter 10,if the user twists and or elongates coil 12 such that distal end 14 ofcoil 12 is within a predetermined distance of proximal end 26 of distalportion 20 then the user would know adapter 10 is safe to insert intomedical device 200. For example, tube 16 can be marked to indicate theappropriate location of distal end 14 of coil 12.

FIG. 4 illustrates an alternate embodiment of the present invention,adapter 40. Adapter 40 has distal portion 41 and proximal portion 42similar to distal portion 20 and proximal portion 30 of adapter 10 asshown in FIGS. 1A, 1B and 1C. Adapter 40 includes tube 16 with funnelportion 13 located at proximal portion 42 of adapter 40. Tube 16 iscoupled to distal portion 41. Coil 12 is also coupled to distal portion41 and interfaces with lumen 211 of medical device 200 in a manner thatsecures adapter 40 to medical device 200. Securement can be achieved ina similar manner as previously described for adapter 10.

FIG. 5 illustrates an alternate embodiment of the present invention,adapter 50. Adapter 50 has distal portion 51 and proximal portion 52similar to distal portion 20 and proximal portion 30 of adapter 10 asshown in FIGS. 1A, 1B and 1C, Adapter 50, which is similar to adapter40, except portion 53 of coil 12 that interfaces with lumen 211 has alarger pitch than that of adapter 40. For example, the pitch can be inthe range of about 2 to about 10 times the size of the coil-sectionalsize of the wire of coil 12. Adapter 50 also includes proximal end 25 ofcoil 12 which is similar to distal end 14 of adapter 10 in both use andform, except coil 12 is elongated and or twisted toward the proximalportion 52 of adapter 50 to make the size of coil 12 smaller tofacilitate insertion of adapter 50 into medical device 200.

FIG. 6 illustrates an alternate embodiment of the present invention,adapter 60. Adapter 60 has distal portion 61 and proximal portion 62similar to distal portion 20 and proximal portion 30 of adapter 10 asshown in FIGS. 1A, 1B and 1C, as well as other similar features.Proximal portion 62 includes coil 12 which has a reduced sized portion18 such that it grips tube 16. Coil 12 can be heat shaped or formed witha portion that interfaces with lumen 211 of medical device 200. Reducedsized portion 18 has an inside diameter dia1 smaller than outsidediameter dia2 of tube 16 to contact and grip tube 16 during use. Reduceddiameter portion 18 of coil 12 can be bonded, glued, heat reflowed totube 16 to further couple coil 12 to proximal portion 62.

FIG. 7 illustrates adapter 70 in a configuration where coil 12 has beenreduced to a smaller size by elongating and or twisting coil 12,similarly illustrated in FIG. 2 and FIG. 3. Adapter 70 has distalportion 71 and proximal portion 72 similar to distal portion 20 andproximal portion 30 of adapter 10 as shown in FIGS. 1A, 1B and 1C.Distal portion 71 includes single lumen tip 73, co-axial withlongitudinal axis 11. Single lumen tip 73 has been reinforced withreinforcement section 74. For example, reinforcement section 74 can be acoil or braid. Reinforcement section 74 includes proximal coil portion75 which extend past the proximal end of single lumen tip 73. Proximalcoil portion 75 provides a slight interference fit with lumen 211 and astable interface during initial insertion of adapter 70 into medicaldevice 200 by the user. Reinforcement section 74 reinforces distalportion 71 and can facilitate tracking medical device 200 through atight lesion.

FIG. 8A, FIG. 8B, FIG. 8C, FIG. 8D, FIG. 8E, and FIG. 8F illustrate analternate embodiment of the present invention, adapter 100. Adapter 100has distal portion 170 and proximal portion 110. Proximal portion 110includes coil 130. Coil 130 is wound from wire 136 and has multiplediameters along its length. In one embodiment, wire 136 is flat with arectangular or square cross-section. For example, coil 130 can have awound length A 131 at a diameter øA 137 at proximal end of coil 130. Thewound pitch of wire 136 along wound length A 131 is variable, notconstant, and changes from a pitch that is approximately twice the width162 of flat wire 136 at proximal end of the wound length A 131 to apitch that is approximately equal to a width of flat wire 136, such thatwire 136 is close wrapped, at distal end of wound length A 131. Avariable pitched wound length has advantages in that the farther spacedpitched coil can be more flexible and the close wrapped coil can bestiffer and stronger in torsion or bending. A variable pitched woundlength also has advantages in that the farther spaced pitched coil canalso provide a better bonding geometry such that a bonding agent oradhesive can flow between wraps of coil 130. As wire 136 is wounddistally to form coil 130 the diameter of the coil 130 transitions froma size øA 137 to a larger size a 138 over length transition 132. Wire136 is wound over length B 133 at a size øB 138. The wound pitch of wire136 along wound length B 133 is variable, not constant, and changes froma pitch that is approximately equal to width 162 of wire 136, such thatwire 136 is close wrapped, to a significantly wider pitch that isapproximately more than 5 times the close wrapped pitch. A dramatic orrapid change in pitch from close wrapped to more than 5 times width 162of flat wire 136 is advantageous because it creates a wedge when coil130 is constrained within internal lumen 211 of medical device 200during use and can improve the interference fit and retention propertiesof adapter 100 within medical device 200. Typically, øA 137 would bedimensionally smaller than lumen 211 of the target medical device 200and øB 138 would be dimensionally larger than lumen 211 of the medicaldevice 200. As wire 136 is wound distally to form coil 130 the diameterof coil 130 transitions from a size øB 138 to a smaller size ØD 139 overlength transition 134. The wound pitch of wire 136 along wound lengthtransition 134 is approximately uniform.

In an alternate embodiment, the wound pitch of wire 136 along woundlength transition 134 is variable. Wire 136 is wound distally fromlength transition 134 to continue to form coil 130 at a size ØD 139 overa wound length D 135. Typically, ØD 139 would be dimensionally smallerthan lumen 211 of medical device 200. A portion of wound length D 135 ofcoil 130 at a size ØD 139 is within cavities 178 and 177 of distalportion 170 of adapter 100. Cavity 177 is sized to interface with adistal end of medical device 200 and cavity 178 is sized to accommodatethe coil 130 at a size ØD 139. Cavity 178 is sized to allow wound lengthD 135 of coil 130 to move freely within cavity 178 when there is not anexternal mechanism gripping, pinching or clamping proximal end of distalportion 170 in the area of cavity 178. When there is an externalmechanism gripping, pinching or clamping the proximal end of distalportion 170 in the area of cavity 178, cavity 178 is sized to prevent aportion of coil 130 in wound length D 135 from rotating or moving,holding coil 130, which has been previously rotated/twisted to a smallersize state to facilitate insertion of proximal portion 110 of adapter100 into medical device 200.

Coil 130 can be made from Nitinol and have an austentic finishtemperature (Af) approximately equal to or less than an ambienttemperature of the operating room or catheter lab environment so coil130 will expand when released from a smaller size state after insertioninto medical device 200. Alternatively, coil 130 can be made fromNitinol and have an austenitic finish temperature (Af) less than bodytemperature but greater than the temperature typically expected in anoperating room or catheter lab, for example about 25 C-30 C, except inzone T 161 where coil 130 has been selectively heat treated to have anaustentic finish temperature (Af) approximately equal to or less than anambient temperature operating room or catheter lab environment, forexample less than about ˜18 C, to enable zone T 161 of Nitinol coil 130to expand when released from a smaller size state after insertion intomedical device 200 in the catheter lab environment. Coil 130 havingmulti-zone or variable thermal properties has advantages in that it canbe easier to insert adaptor 100 into medical device 200 with some ofcoil 130 having a higher Af temperature. The selectively heat treatedportion of coil 130 in zone T 161 is biased to engage internal lumen 211of medical device 200 more than the rest of coil 130 to facilitatecreating the wedge, as described above, after coil 130 is released froma smaller size state and constrained within internal lumen 211 ofmedical device 200. As adapter 100 warms to body temperature during usein-vivo the zone T is 161 of coil 130 provides additional securement andstructure to adapter 100. Zone T 161 as shown includes portion of lengthA 131, transition 132 and portion of length B 133. Alternatively, zone T161 can include just a portion of transition 132 and a portion of lengthB 133 or other combinations.

Coil 130 is coupled to, bonded to or otherwise attached to central tube182 of central lumen 183 of adapter 100 at part or all of the woundlength A 131 at øA 137. Proximal end 120 of proximal portion 110 ofadapter 100 includes inner element 122 and outer element 121. Innerelement 122 and outer element 121 can form a funnel shape. Outer element121 can be radiopaque or partially radiopaque to provide a landmark forproximal end 120 of adapter 100 when used in-vivo. The funnel shape ofproximal end 120 of the adapter 100 can facilitate the back loading of aguidewire through the medical device 200 and adapter 100 during use.Proximal end 120 of adapter 100 is coupled, bonded or otherwise attachedto the central tube 182. In one embodiment, central tube 182 can beunitary with inner element 122.

Central tube 182 connects proximal end of coil 130, in the area ofLength A 131 and proximal end 120 to distal portion 170. Distal portion170 of adapter 100 has an outer body 179 that is typically cylindricalor a revolved shape. Alternatively, outer body can have a non-revolvedprofile in portions or entirely. Outer body 179 can be made from apolymer. Outer body can be reinforced with metal, polymer or ceramicfibers, wire, laser cut hypotube and the like. Outer body 179 can be alaminated structure which can include multiple tube elements ormaterials. Outer body 179 can have a stepped tapered shape with firstoutside diameter 185 and second outside diameter 184 connected bytapered portions. Distal portion 170 has first exit lumen 186 of centrallumen 183 and second exit lumen 187 of central lumen 183 at oppositeeach other in outer body 179. First exit lumen 186 is angled at angle A1toward proximal portion 110 of adapter 100 from the central axis ofcentral lumen 183. An angle in a direction of angle A1 can beadvantageous when a guidewire is tracked through central lumen 183starting at distal tip 181 of distal portion 170, exiting through firstexit lumen 186. Second exit lumen 187 is angled at angle A2 towarddistal end of adapter 100 from the central axis of central lumen 183. Anangle in a direction of angle A2 can be advantageous when a guidewire istracked through central lumen 183 at proximal end 120 of proximalportion 110, exiting through second exit lumen 187. Central tube 182terminates proximal to distal tip 181 such that a portion of centrallumen 183 is formed only by outer body 179. Alternatively, central tube182 could extend to distal tip 181 or terminate at a more proximallocation within outer body 179. Central tube 182 can form central lumen183 for a majority of the length of distal portion 170 to add strengthand rigidity if required, for example if central tube 182 was a braidedor wire reinforce structure.

In one embodiment, coil 130 has been rotated or twisted about thelongitudinal axis of coil 130 and central tube 182 while central tube182 and portion of wound length A 131 at øA 137 attached to central tube182 are held fixed to decrease its size, specifically in transition 132,length B 133, and transition 134. After coil 130 has been rotated ortwisted to decrease the size of transition 132, length B 133, andtransition 134, a portion of distal end 198 of coil 130, length D 135,which is already at a small diameter can be held and fixed relative todistal portion 170 and coupled central tube 182 such that the coil 130will remain at a reduced diameter. When a portion of distal end 198 ofcoil 130, length D 135 that was held is released coil 130 will expandback from the small size state to its unconstrained size state and thisexpansion will tend to happen starting at unattached distal end 197,length D 135 as coil 130 starts to expand/unwind from the distal end andprogressively expands/unwinds moving proximal. In one embodiment, coil130 progressively expands/unwinds from distal end 197 to proximal end ofcoil 130, distal elements of coil 130 do not substantially inhibit theexpansion and engagement of the portion transition 132 and Length B 133to internal lumen 211 of medical device 200, facilitate creating thewedge.

FIG. 9A, FIG. 9B, FIG. 9C, FIG. 9D, FIG. 9E, FIG. 9G and FIG. 9Hillustrate an alternate embodiment of the present invention, adapter101. Adapter 101 is similar to Adapter 100 and has distal portion 171and proximal portion 111. Proximal portion 111 includes coil 140 whichis similar to coil 130. Coil 140 is wound from wire 136 and has multiplediameters along the length of coil 140. Coil 140 as shown has a woundlength A 141 at a diameter øA 137 at proximal end 157 of coil 140. Thewound pitch of wire 136 along wound length A 141 is variable, notconstant, and changes from a pitch that is approximately twice the width162 of flat wire 136 at the proximal end of the wound length A 141 to apitch that is approximately equal to the width 162 of wire 136, suchthat wire 136 is close wrapped, at the distal end of wound length A 141.A variable pitched wound length has advantages that the farther spacedpitched coil can be more flexible and the close wrapped coil can bestiffer and stronger in torsion or bending. A variable pitched woundlength can have advantages in that the farther spaced pitched coil canalso provide an improved bonding geometry such that a bonding agent oradhesive could flow between wraps of coil 140. As wire 136 is wounddistally to form coil 140 the diameter of the coil 140 transitions froma size øA 137 to a larger size a 138 over length transition 160. Wire136 is wound over a length B 133 at a size a 138. The wound pitch ofwire 136 along wound length B 133 is variable, not constant, and changesfrom a pitch that is approximately equal to width 162 of wire 136, suchthat wire 136 is close wrapped, to a significantly wider pitch that isapproximately more than 5 times width 162 of the flat wire 136. Adramatic or rapid change in pitch from close wrapped to more than 5times the width 162 of wire 136 as shown is advantageous because itcreates a wedge when coil 140 is constrained within internal lumen 211of medical device 200 during use and can improve the interference fitand retention properties of adapter 101 within the catheter or device200. Typically, øA 137 would be dimensionally smaller than lumen 211 ofmedical device 200 and a 138 would be dimensionally larger than lumen211 of the medical device 200. As wire 136 is wound distally to formcoil 140 the diameter of coil 140 transitions from size a 138 to asmaller size øC 144 over length transition 142, the wound pitch of wire136 along wound length transition 142 is substantially uniform.Alternatively, wound pitch of wire 136 along wound length transition 142is variable. Wire 136 is wound distally from length transition 142 tocontinue to form coil 140 at a size øC 144 over wound length C 143. øC144 can be dimensionally similar to or slightly smaller than lumen 211of medical device 200 so that as coil 140 was unconstrained from a smallsize state in use to secure adapter 101 to internal lumen 211, woundlength C 143 of coil 140 at size øC 144 would be less likely to inhibitwound length B 133 of coil 140 at size a 138 from engaging and securingcoil 140 to internal lumen 211 of medical device 200. As wire 136 iswound distally to form coil 140 the diameter of coil 140 transitionsfrom size øC 144 to a smaller size ØD 139 over length transition 146,the wound pitch of wire 136 along wound length transition 146 issubstantially uniform. Alternatively, wound pitch of wire 136 alongwound length transition 146 is variable. Wire 136 is wound distally fromlength transition 146 to continue to form coil 140 at a size ØD 139 overwound length D 145. Typically, ØD 139 would be dimensionally smallerthan lumen 211 of medical device 200. A portion of the wound length D145 of coil 140 at a size ØD 139 is within cavities 178 and 177 atproximal end 199 of distal portion 171 of adapter 101. Cavity 177 issized to interface with distal end (not shown) of medical device 200 andcavity 178 is sized to accommodate coil 140 at a size ØD 139.

Cavity 178 is sized to allow wound length D 145 of coil 140 to movefreely within cavity 178 when there is not an external mechanismgripping, pinching or clamping proximal end 199 of distal portion 171 inthe area of cavity 178. When there is an external mechanism gripping,pinching or clamping proximal end 199 of distal portion 170 in the areaof cavity 178, cavity 178 sized to prevent a portion of coil 140 inwound length D 145 from rotating or moving, holding coil 140, which hasbeen previously rotated/twisted to a smaller size state to facilitateinsertion of proximal portion 111 of adapter 101 into medical device200.

Coil 140 is coupled to, bonded to or otherwise attached to second tubeelement 190 forming a portion of second lumen 191 of adapter 101 at oralong part or all of the wound length 141 at øA 137. It may beadvantageous for wound length 141 to be attached to second tube element190 predominately close to transition 160 such that an uncoupled portionof wound length 141 could extend proximally to add more structure andsupport to adapter 101 and medical device 200. Proximal end 120 ofadapter 101 is attached to second tube element 190 in a similar manneras proximal end 120 of adapter 100 is attached to central tube 182.

Distal portion 171 of adapter 101 has outer body 179 that is typicallycylindrical or a revolved shape. Alternatively, distal portion 171 ofadapter 101 has outer body 179 that has a non-revolved profile inportions or all, similar to outer body 179 of adapter 100 shown in FIG.8A. Second tube element 190 is attached or coupled to outer body 179,thereby connecting proximal end of coil 140, in the area of Length A 141and proximal end 120 to distal portion 171. Distal portion 171 has firsttube element 188 which forms a portion of first lumen 189. As shown,first tube element 188 terminates proximal to distal tip 181 such that aportion of first lumen 189 is formed only by the outer body 179. Firsttube element 188 could extend to distal tip 181 or terminate at a moreproximal location within outer body 179. Second lumen 191 and firstlumen 189 exit outer body 179 in a manner similar to second exit lumen187 and first exit lumen 186. Second tube element 190 and first tubeelement 188 are shown extending to edge 230 of outer body 179 of distalportion 171. Alternatively, second tube element 190 and first tubeelement 188 can terminate before edge 230 and such that a portion ofsecond lumen 191 and first lumen 189 can be formed by outer body 179 ofdistal portion 171.

FIG. 10A, FIG. 10B, FIG. 10C, FIG. 10D, FIG. 10E, FIG. 10F and FIG. 10Gillustrate an alternate embodiment of the present invention, adapter102. Adapter 102 is similar to adapter 100 and has distal portion 172and proximal portion 112. Proximal portion 112 includes coil 130 locatedcloser to distal portion 172 and coil 147 located closer to proximal end123. Coil 130 is a left handed helix and coil 147 is a right handedhelix. Coil 130 has been described as part of adapter 100. Coil 147 issimilar to coil 130. Coil 147 is wound from wire 153 and has multiplediameters along the length of the coil 147. Wire 153 can be a flat wire.Coil 147 as shown has a wound length E 148 at a diameter (ø) øE 151 atthe proximal end of coil 147. As wire 153 is wound distally to form coil147 the diameter of coil 147 transitions from a size øE 151 to a largersize øF 152 over a length transition 149. Wire 153 is wound over alength F 150 at a size øF 152. The wound pitch of 153 along wound lengthF 150 is variable, not constant, and changes from a pitch that isapproximately equal to the width of wire 153, such that wire 153 isclose wrapped, to a significantly wider pitch that is approximately morethan 5 times the width of wire 153. A dramatic or rapid change in pitchfrom close wrapped to more than 5 times the width of wire 153 isadvantageous because it creates a wedge when coil 147 is constrainedwithin internal lumen 211 of medical device 200 during use and canimprove the interference fit and retention properties of adapter 102within medical device 200. Typically, øE 151 would be dimensionallysmaller than lumen 211 of medical device 200 and the øF 152 would bedimensionally larger than lumen 211 of medical device 200.

Adapter 102 includes coaxial tube elements, central tube 192 andreinforcing tube member 194. Central tube 192 forms a portion of centrallumen 193 of adapter 102. Proximal end 123 of adapter 102 is attached orcoupled to the central tube 192. Proximal end 123 is comprised of funnelelement 124. Central tube 192 and funnel element 124 can be unitary suchthat funnel element 124 is a flared end of central tube 192. Funnelelement 124 is advantageous in that it can facilitate back loading aguide wire through the medical device 200 and adapter 102. Central tube192 and reinforcing tube member 194 are both attached, bonded or coupledto distal portion 172 of adapter 102. As shown, reinforcing tube member194 terminates proximally to central tube 192 which terminates proximalto distal end 181 of proximal portion 172 of adapter 102. An alternateembodiment or configuration can have reinforcing tube member 194attached to distal portion 172 and central tube 192 attached toreinforcing tube member 194 to form adapter 102. This embodiment hasadvantages if reinforcing tube member 194 were to terminate closer todistal tip 181 to include features to optimize the tip performance, forexample as a crossing support device, while central tube 192predominately provides a more optimized central lumen 193 for a guidewire as an example. In this embodiment, reinforcing tube member 194 andcentral tube 192 can terminate approximately together or central tube192 can be more proximal than reinforcing tube member 194.

Coil 147 is attached, bonded or otherwise coupled to the reinforcingtube member 194 at all or a portion of length E 148. This could beaccomplished using an adhesive to attach a portion of length E 148 toreinforcing tube member 194. In a similar manner as previouslydescribed, a portion or all of the length A 131 of coil 130 is bonded orattached to reinforcing tube member 194.

The inside diameter of coil 130 at a size of øD 139 is typically largerthan the outside diameter of second tube element 190 or central tube 182or reinforcing tube member 194.

FIG. 11A, FIG. 11B, FIG. 11C, and FIG. 11D, illustrate adapter 102 whilecoil 130 has been rotated or twisted in a manner that wraps or winds itdown to a smaller diameter øB 155. Coil 130 has been rotated or twistedsuch transition 132, wound length B 133 and transition 134 have beenmade to be held in a state at a smaller diameter øB 155 over a combinedwound length of transitions 132 and length B 154. Diameter øB 155 isapproximately equal to or smaller than internal lumen 211 of medicaldevice 200 to facilitate inserting adapter 102. Temporary constrainingelement 195 is positioned around this portion of coil 130 to secure coil130 at smaller diameter øB 155. Temporary constraining element 195 isadvantageous to allow coil 130 to be held in smaller diameter øB 155without the need to hold or restrain from moving length D 135 section ofcoil 130. Length D 135 is not attached or coupled to reinforcing tubemember 194.

FIG. 11A, FIG. 11B, FIG. 11C, and FIG. 11D show clamping element 196pinching or holding a portion of Length D 135 from rotating such thattemporary constraining element 195 can be removed and coil 130 wouldstill be held in a state that includes smaller diameter øB 155. It maybe advantageous to include a temporary constraining element 195 suchthat only temporary constraining element 195 holds coil 130 in a stateat a smaller diameter øB 155 in an adapter packaging suitable forterminal sterilization and or shipping, transportation and inventory atthe customer site, this would minimize the amount of time the load atthe attached portion of coil 130 in Length A 131 would need to bereacted. When the adapter is ready to be used in an operating room orcatheter lab, clamping element 196 can be applied and temporaryconstraining element 195 can be removed to allow insertion into medicaldevice 200.

FIG. 12A, FIG. 12B, FIG. 12C, and FIG. 12D, illustrate adapter 102 afterit has been initially inserted into medical device 200 while coil 130has been rotated or wound down to a smaller diameter øB 155 and held inthat positon by clamping element 196. Coil 147 is shown after it hasbeen inserted in internal lumen 211 of medical device 200. As coil 147is inserted the portion of length F 150 and transition 149 as shown inFIG. 11A, FIG. 11B, FIG. 11C, and FIG. 11D conforms to the size of innerlumen 211 of medical device 200 and becomes a smaller diameter ø″ 159 byelongating and or rotating. Similarly to as described previously, adramatic or rapid increase in pitch from close wrapped to more than 5times the close wrap pitch which is approximately the width of wire 153,as shown is advantageous because it creates a wedge with an angle A 127,equal to or greater than approximately 15 degrees, when coil 147 isconstrained within internal lumen 211 of medical device 200 during useand can improve the interference fit and retention properties of adapter100 within medical device 200. In the embodiment of adapter 102, coil147 is the leading coil inserted into internal lumen 211 of medicaldevice 200. As coil 147 is inserted into internal lumen 211, the wrapsof wire 153 that are at a size approximately equal to internal lumen211, located within transition 149 and length F 150, engage wall 212 ofinternal lumen 211 and reduce in size by elongating and rotating(predominately elongating) such that the transition and length F 158 islonger than combination of transition 149 and length F 150 and theentire coil 147 can be inserted into medical device 200. This mode ofaction is different than that of coil 130.

As shown in FIG. 13A, FIG. 13B, FIG. 13C, and FIG. 13D after adapter 102is inserted into target device or catheter 200 and clamping element 196is removed, coil 130 will rotate and expand to the size of internallumen 211 to engage the walls 212 of internal lumen 211, over a combinedwound length of length B 156 which includes portions of transition 132,length B 133, and transition 134. Coil 130 is designed such that, uponexpansion to conform to internal lumen 211 as described, within coil 130geometry there is a dramatic or rapid increase in pitch from closewrapped to more than 5 times the close wrap pitch which is approximatelythe width of wire 136 which creates a wedge with an angle B 163, equalto or greater than approximately 15 degrees. An advantage to the mode ofaction of coil 130 versus the mode of action of coil 147 is that bypredominantly rotating coil 130 to conform to the internal lumen 211instead of predominately elongating coil 147 to conform to the internallumen 211, coil 130 will be less likely to have axial re-coil whenallowed to expand and the force to insert adapter is removed. Coil 147can be pulled into the lumen 211 of medical device 200 as adapter 102 isinserted into medical device 200 via the bonded connection in Length A131 to reinforcing tube member 194. After adapter 102 has been insertedinto medical device 200, coil 147 will tend to axially re-coil towarddistal end of adapter 102, whereas coil 130 rotates into positionwithout an external pulling force. Including both modes of action in oneadapter is advantageous because it provides redundancy in case one modeis less effective than the other in retaining adapter 102 in medicaldevice 200. Additionally, coil 130 and coil 147 are wound in oppositedirections such that if adapter 102 is placed under an externaltorsional load, adapter 102 optimally reacts in either direction of anexternal torsional load.

FIG. 14A, FIG. 14B, and FIG. 14C, illustrate adapter 103 after it hasbeen inserted into medical device 200 and coil 130 has been deployed toengage internal lumen 211 securing adapter 103. Adapter 103 includesdistal portion 173 and proximal portion 113 very similar to previouslydescribed proximal portion 110 and proximal portion 111. Distal portion173 of adapter 103 has outer body 179 that is typically cylindrical or arevolved shape. Alternatively, distal portion 173 of adapter 103 canhave a non-revolved profile in portions or all. Outer body 179 has astepped tapered shape with first outside profile 185, second outsideprofile 184 and third outside profile 180 connected by tapered portions.Distal portion 173 has first tube element 188 which forms a portion offirst lumen 189. First tube element 188 terminates proximal to distaltip 181 such that a portion of first lumen 189 is formed only by outerbody 179. First tube element 188 could extend to distal tip 181 orterminate at a more proximal location within outer body 179. Second tubeelement 190, which forms a portion of second lumen 191, connects coilelement 130 of proximal portion 113 to distal portion 173. Second lumen191 and first lumen 189 exit outer body 179 in a manner similar tosecond exit lumen 187 and first exit lumen 186. Second tube element 190and first tube element 188 are shown partially extending to edge 230 ofouter body 179 of distal portion 173 where a portion of second tubeelement 190 and first tube element 188 terminate before 230 edge ofouter body 179 such that a portion of second lumen 191 and first lumen189 are formed by outer body 179 of distal portion 173. Third outsideprofile 180 of outer body 179 includes first cavity 166 and secondcavity 169, as shown in longitudinal cross section and transverse crosssection Z-Z. First cavity 166 and second cavity 169 are shown as opencavities. Alternatively, first cavity 166 and second cavity 169 can be aclosed cavity, such as a circle shaped cavity. First cavity 166 andsecond cavity 169 are shown to be 180 degrees opposite each other.Alternatively, first cavity 166 and second cavity 169 can havealternative orientations.

FIG. 15A, FIG. 15B, and FIG. 15C, illustrate adapter 103, as shown inFIG. 14A, FIG. 14B, and FIG. 14C with the addition of first wire 167 andsecond wire 168. Preferably, first wire 167 originates with a first endoutside the patient (not shown) and extends distally along the outsideof medical device 200 then through first cavity 166 and first lumen 189exiting distal end 181 of distal portion 173 and extends to second end231 of first wire 167. Preferably, second wire 168 originates with afirst end outside the patient (not shown) and extends distally throughproximal end (not shown) of medical device 200 and continues insidelumen 211 of medical device 200, through second lumen 191 then wrappingto extend back proximally through second cavity 169 extending proximallyalong the outside of medical device 200 and extends to second end (notshown) of second wire 168. Second end (not shown) of second wire 168 canterminate outside the patient body. Adapter 103 can be advantageous whenmedical device 200 is a percutaneous transluminal angioplasty balloon.First wire 167 can act a guide wire to track medical device 200 which isa percutaneous transluminal angioplasty balloon to the site of anarterial lesion or blockage as well as provide a mechanism to induce astress concentration into the wall of the artery and lesionpreferentially dissecting or disrupting the lesion to improve dilationperformance of the balloon at the target lesion. Second end of secondwire 168 can extend proximally past the balloon in medical device 200such that second wire 168 also provides a mechanism to induce a stressconcentration similar to first wire 167. Second wire 168 can have curve164. For example, second wire 168 can be manufactured from Nitinol andbe heat treated to set a shape with curve 164. Alternately, second wire168 can be designed to be readily shaped to curve 164. For example,second wire 168 can be manufactured from Nitinol and be heat treated tohave an Af temperature such that second wire 168 is easily bent to curve164 and stays in that shape during use, for example at an Af temperatureabove body temperature (37C). Second wire 168 can be positioned intoadapter 103 and medical device 200 of a balloon prior to introduction ofadapter 103 and medical device 200 into the patient. After theballooning procedure is completed, second wire 168 can be withdrawn fromproximal end (not shown) of medical device 200. Alternatively, secondwire 168 is tracked through medical device 200 and positioned in-vivo.

FIG. 16A, FIG. 16B, and FIG. 16C, illustrate adapter 104 which issimilar to adapter 103. Adapter 104 includes distal portion 174 whichincludes third outside profile 126 of outer body 179. Second wire 125includes first end 232 which is coupled or attached to outer body 179 attop or edge 233 of third outside profile 126. Second wire 125 extendsproximally from outer body 179 and distal portion 174 along the outsideof medical device 200 and extends to second end (not shown) of secondwire 125. Second end (not shown) of second wire 125 can terminate withinthe artery or body vessel in a loop or fold to minimize any chance ofincidental vessel trauma or extend all the way proximally exiting thepatient. As shown in transverse cross section view Z-Z of third outsideprofile 126, there is no cavity in third outside portion 126 for firstwire 167. First wire 167 alternatively extends distally alongside thirdoutside profile 126.

The size of first outside profile 185, second outside profile 184, andthird outside portion 126 generally increase in size from first outsideprofile 185 to third outside profile 126. However, third outside profile126 has a reduced size portion 165 which is approximately equal in sizeto second outside profile 184. This can be advantageous in that therewould be room for second wire 125 to fold back and extend distally asmedical device 200 and adapter 104 is withdrawn from the artery andpatient.

FIG. 17A, FIG. 17B, and FIG. 17C, illustrate adapter 105 which issimilar to adapter 101. Adapter 105 includes distal portion 175. Distalportion 175 has outer body 179 that is typically made from a softpolymer or elastomeric polymer. Distal portion 175 incorporates firsttube element 188 that forms a portion of first lumen 189 in outer body179. First lumen 189 exits outer body 179 distally at distal tip 181.First lumen 189 is formed partially by first tube element 188 and outerbody 179. First lumen 189 exits outer body 179 proximally at exit 253which is proximal to distal exit 254 of second lumen 191 from outer body179. Second lumen 191 is formed partially by second tube element 190 andouter body 179. As shown in section Y-Y, second lumen 191 transitionsfrom a closed section as it exits outer body 179. Tube element 188 andtube element 190 are side by side and overlap for length 251 withinouter body 179. First lumens 189 and second lumen 191 overlap for length255. An alternate embodiment of distal portion 175 includes first lumen189 formed entirely by outer body 179 without tube element 188. Distalportion 179 also includes a hole or passage 252 into cavity 178 close todistal end 234 of cavity 178. Hole 252 can be beneficial to facilitateflushing air out of cavity 178 prior to use. Hole 252 can also providean additional conduit to deliver fluids or contrast through lumen 211 ofmedical device 200.

FIG. 18A, FIG. 18B, FIG. 18C, FIG. 18D, FIG. 18E, and FIG. 18Fillustrates an alternate embodiments of coil 257 of proximal portion 113of an adapter 105 of the present invention. Coil 257 has a variablediameter and pitch. Similar to the other coil embodiments, coil 257 hasa proximal diameter (ø) øE 151 and a larger diameter (ø) øF 152 atdistal end 270 of coil 257. Coil 257 transitions in diameter from øE 151to øF 152. Coil 257 is bonded or otherwise attached to central tube 263that forms a portion of a central lumen 271 similar to central tube 182over a length G 258. The unbonded distal portion, Length H1 272, of coil257 includes a portion at a diameter øE 151, a portion at diameter øF152 and a portion where the diameter transitions between those twodiameters. The unbonded distal portion, Length H1 272, of coil 257 isshown with a variable pitch that are not close wrapped, but couldinclude close wrapped pitch. A close wrapped pitch in the unbondeddistal portion 272 at the smaller diameter and in the transition to thelarger diameter can be advantageous as there can be less axial movementof central tube 263 under an axial load after the adapter 105 isattached to a target medical device 200. FIG. 18B illustrates coil 257of proximal portion 113 of an adapter 105 after adapter 105 has beeninserted and seated into medical device 200 with lumen 211 as previouslydescribed. As coil 257 is inserted, the unbonded distal portionelongates to a length H2 259, such that a portion of coil 257 forms anangle A 127 as previously described. Proximal portion 113 also includesproximal end 120 and is comprised of inner element 122 that forms afunnel and outer element 256. Outer element 256 is similar to outerelement 121 and could be radiopaque or partially radiopaque to provide alandmark for the proximal end of the adapter in-vivo, but is shorter anddoesn't fully cover inner element 122, is longitudinally shorter inlength than inner element 122.

FIG. 18C shows an embodiment of proximal portion 113 and coil 257 suchthat after inserting and seating into a target device 200 as describedand the central tube 263 is placed under an axial load F 261 theunbonded distal portion, Length H3 260, of coil 257 becomes shorter thanthe length H2 259 prior to the axial load F 261. Additionally, a portionof the unbonded coil wraps that formed unbonded distal portion length H2compress together axially under the axial load F 261 and touch eachother, effectively completing the wedge formed by angel A 127, asillustrated in the enlarged detail view FIG. 18E.

FIG. 18D shows yet another embodiment of the proximal portion 113 andcoil 257 such that after inserting and seating into medical device 200as described and the central tube 263 is placed under an axial load F261 the unbonded distal portion, Length H4 262, of coil 257 becomesshorter than the length H2 259 prior to the axial load F 261.Additionally, a portion of the unbonded coil wraps that formed unbondeddistal portion length H2 259 compress together axially under the axialload F 261 and touch each other as well as nest inside or invaginateeffectively completing the wedge formed by angel A 127, as illustratedin the enlarged detail view FIG. 18F. Nested coil wraps as illustratedin FIG. 18D and FIG. 18F may be advantageous as it may increase thesecurement of the adapter.

It could be envisioned that multiple coils similar to coil 257 could bebonded to a central tube 263 in series to create proximal portion 113.Proximal portion 113 of this design can increase the robustness of thesecurement of the adapter to medical device 200. A multiple coilconfiguration of this nature can include both left and right hand coilsas previously described to minimize a bias or potential securement issuewhen central tube 263 is place under a torsional load.

FIG. 19 illustrates an embodiment of proximal portion 114 of an adapterthat includes a coil 264 similar to coil 257. Coil 264 includes all theelements of coil 257 plus a section of unbonded length J 265 thattransitions from a larger diameter of 152 to a smaller diameter that ispreferentially smaller than the diameter of the inner lumen 211 ofmedical device 200, similar to a diameter of 151. A coil design of thisnature can be advantageous as it allows proximal portion 114 to beremoved from medical device 200. Proximal portion 114 can be removed bya user gripping a coil wrap in length J 265 and pulling distallyelongating and or rotating coil 264, releasing the wedge securement atthe inside diameter of lumen 211 of target device 200. For example, if aproximal portion 114 were coupled to a distal portion similar to 102 toform an adapter and a portion of length J 265 of coil 264 extended intocavity 178 after proximal portion 114 were inserted and seated intomedical device 200, similar to length D 135 as shown in FIG. 13D,effectively extending out the distal end 213 of medical device 200, theuser could cut distal portion 102 at a point along cavity 178,effectively separating distal portion 102 from proximal portion 114 suchthat the user can grip and pull distally a coil wrap in length J 265,removing proximal portion 114 from medical device 200. It is understoodthat a length of wire 153 or an extension of wire 153 extending out ofmedical device 200 is gripped to remove proximal portion 114.

FIG. 20A and FIG. 20B show proximal portion 115 with coil 266 that issimilar to coil 130. Coil 266 includes a transition 267 that varies indiameter and pitch. Coil 266 also includes a length K 268 at a diametera 138 that is predominately wider spaced pitch and a variable pitchtransition to a diameter øD 139. A design similar to this may have anadvantage in securement when inserted into medical device 200 asdescribed for coil 130. It is understood that coils constructed similarto coil 130 and coil 266 can alternatively be inserted into medicaldevice 200 similarly to coil 257 and still provide securement afterinsertion.

FIG. 21A, and FIG. 21B, illustrate an alternate embodiment of a distalportion 176 of adapter 106. Adapter 106 includes distal portion 176.Adapter 106 has been inserted into medical device 200. Distal portion176 includes first lumen 273, outer body 179, second tube element 190forming a portion of second lumen 191 of adapter 106. First lumen 273exits outer body 179 proximally at exit 253 which is proximal to distalexit 254 of second lumen 191 from outer body 179. Outer body 179includes taper portion 274 to proximally interface and engage with wall212 of distal inner lumen 211 of medical device 200. Taper portion 274interfaces and engages with medical device 200 and can reduce theoverall size or profile of adapter 106. Distal portion 176 includesreinforcing coil 275 which spans transition portion 276 between medicaldevice 200 and distal portion 176. Reinforcing coil 275 can reduce thechance of the medical device 200 or adapter 106 kinking at or neartransition 276. Reinforcing coil 275 is smaller in size or diameter thaninner lumen 211 and is partially attached to outer body 179 and distalportion 176. Distal portion 176 also includes distal tip 181. Whenattached to a medical device 200, the first lumen 273 can be used as aguide for a first guidewire, while the second lumen 191 can be used tointroduce a second guidewire or other accessory into the patient. Forexample, an accessory with drill bit like features or characteristicsthat could be used to penetrate the cap of a completely occluded lesionmay be advantageous.

It is to be understood that the above-described embodiments areillustrative of only a few of the many possible specific embodiments,which can represent applications of the principles of the invention.Numerous and varied other arrangements can be readily devised inaccordance with these principles by those skilled in the art withoutdeparting from the spirit and scope of the invention.

For example, the nitinol coil structure could be replaced by a braidedwire structure as it could be readily change size by elongating tofacilitate insertion into medical device 200. A braided wire structurecan be manufactured from nitinol and have similar thermal-mechanicalproperties as the nitinol coil or can be made from a more traditionalalloy, such as stainless steel and be designed to collapse to a smallerdiameter as it is inserted or prior to insertion into medical device200. A braid structure could be designed to have a similar wedgegeometry when inserted into lumen of target catheter.

Instead of the user reducing the size of the nitinol coil or similar,the adapter can be manufactured and delivered to the customer constrainin that shape ready to be inserted into target catheter or device. Thiswould remove some of the burden from the user and possibly make iteasier to use. The coil could also be a more traditional alloy withoutshape memory or superelastic thermal-mechanical properties such asstainless steel.

Additionally, for configurations where the nitinol coil is coupled tothe distal portion of adapter, the tube could be optional.

Although distal portion of adapter is generally shown to be the similarsize as the target catheter or device this is not require, but may bedesired.

If a second lumen or central lumen is not required, the elongatedelement that the proximal portion of coil structure is attached to couldbe solid as in a wire or mandrel instead of a tube. The tube, wire ormandrel could extend proximally all the way out the proximal end of thetarget catheter or device. Outer body of distal portion could havemultiple and varied profiles. Lumens exiting outer body of distalportion could be at varied angles instead of 180 degrees opposite eachother, including on the same side of outer body of distal portion.

What is claimed is:
 1. An adapter for a medical device comprises: anelongate body; and an attachment element comprising a first portionconnected to the elongate body and a second portion comprising acompressible element, wherein the compressible element is configured toengage a distal end of an inner lumen of a medical device to securelycouple the adapter to the medical device.
 2. The adapter of claim 1,wherein the attachment element is located at a proximal portion of theelongate body.
 3. The adapter of claim 2, wherein the compressibleelement is further configured to be compressed and inserted inside ofthe distal end of the inner lumen of the medical device.
 4. The adapterof claim 3, wherein the second portion of the attachment element isdistal to the first portion of the attachment element.
 5. The adapter ofclaim 4, further configured such that a distal portion of the elongatebody extends beyond the distal end of the inner lumen of the medicaldevice when the adapter is coupled to the medical device.
 6. The adapterof claim 1, wherein the second portion of the attachment elementcomprises a metallic structure.
 7. The adapter of claim 1, wherein thesecond portion of the attachment element comprises a coil structure. 8.The adapter of claim 1, wherein the second portion of the attachmentelement comprises a braided structure.
 9. The adapter of claim 1,wherein the medical device is a catheter.
 10. The adapter of claim 9,wherein the elongate body further comprises a lumen.
 11. An adapter fora medical device comprises: a proximal portion and a distal portion; anattachment mechanism positioned at the proximal portion of the adapter,the attachment mechanism comprises an interfacing element and anelongated element and the elongated element connects the attachmentmechanism to the distal portion of the adapter; and wherein the medicaldevice comprises a proximal end that is configured to remain outside thebody of a patient and a distal end that is configured to go inside thebody of a patient, and the attachment mechanism is configured to couplethe adapter to a distal end of an inner lumen of the medical device. 12.The adapter of claim 11 wherein a portion of the interfacing elementcompresses to couple the adapter to the distal end of the inner lumen ofthe medical device.
 13. The adapter of claim 11 wherein the interfacingelement includes a first portion that is attached to a portion of theelongated element and a second portion that is free from the elongatedelement.
 14. The adapter of claim 11 wherein a portion of the distalportion of the adapter extends beyond the distal end of the inner lumenof the medical device when the adapter and the medical device arecoupled together.
 15. The adapter of claim 13 wherein at least a portionof the second portion of the interfacing element is configured to becompressed to couple the adapter to the distal end of the inner lumen ofthe medical device.
 16. The adapter of claim 13 wherein the secondportion of the interfacing element is distal to the first portion ofinterfacing element.
 17. The adapter of claim 13 wherein the secondportion of the interfacing element comprises a coil structure.
 18. Theadapter of claim 13 wherein the second portion of the interfacingelement comprises a braided structure.
 19. The adapter of claim 13wherein the second portion of the interfacing element comprises acompressible metallic element.
 20. A method of adapting a medical devicecomprises: compressing a compressible element on a proximal portion ofan adapter while inserting the proximal portion into a distal end of aninner lumen of a medical device to securely couple the adapter to themedical device.